Skip to main content
OpenTrials
Completed

NCT Number: NCT05514210

Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD

This study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

About this study

This study is a multicenter, randomized controlled trial. According to the inclusion and exclusion criteria, patients with complex coronary artery disease undergoing elective coronary angiography will be prospectively enrolled in the study. Patients will be randomly assigned to the real-time heart team group and the conventional heart team group by block randomization. The real-time heart team group needs to conduct multidisciplinary heart team discussion during the coronary angiography process, while the traditional heart team group needs to conduct multidisciplinary heart team discussion offline and face-to-face after the coronary angiography process. This study will prospectively collect the patient information, heart team meeting process, clinical treatment, and clinical outcomes to evaluate the efficiency and feasibility and differences in clinical outcomes of patients under different heart team approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Significant stenosis in the left main or left main equivalent with or without stenosis in one of the other vessels[Significant stenosis is defined as: 1) a diameter stenosis of at least 50% reduction in luminal diameter by visual assessment or 2) any total occlusion (no age limitation and no exclusion of unfavorable anatomic features); Left main equivalent disease is defined as significant stenosis of the ostium of the left anterior descending and the ostium of the left circumflex.]
  • At least 1 significant stenosis (≥ 70% obstruction) in all 3 major epicardial territories supplying viable myocardium;
  • Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.

Exclusion criteria

  • Less than 18 years of age;
  • Previous history of PCI or CABG;
  • Admitted for AMI, ECG and biomarker detection indicated acute stage;
  • Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment;
  • Combined with AF or severe arrhythmia;
  • Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization;
  • Rejection or exclusion of a revascularization mode (PCI or CABG);
  • Refuse to participate in the study.

Treatment and study plan

heart team meeting and discussion

Behavioral

When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.

Primary outcomes

  1. 1-year major adverse cardiovascular and cerebrovascular events

    Time frame: At 1 year after the coronary angiography

    a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.

Secondary outcomes

  1. time interval between the completion of coronary angiography and the final treatment

    Time frame: through treatment completion, an average of 60 days

    time interval is considered as a key secondary outcome

  2. revascularization decision-making

    Time frame: through study completion, an average of 1 year

    to assess the distribution of the revascularization decision-making made jointly by the heart team and the patients, such as CABG, PCI or medical therapy

  3. revascularization decision-making guideline adherence

    Time frame: through study completion, an average of 1 year

    adjudicated according to 2018 European Society of Cardiology (ESC)/ European Association for Cardio-Thoracic Surgery (EACTS) guideline

  4. heart team decision-making

    Time frame: through study completion, an average of 1 year

    to assess the distribution of the decision-making made by the heart team, such as CABG, PCI or medical therapy

  5. workload of heart team specialists

    Time frame: through study completion, an average of 1 year

    to assess the workload of the specialists participating in the heart team meetings by NASA-TLX scale

  6. success rate of heart team organization

    Time frame: through study completion, an average of 1 year

    to assess the successful-connection with cardiac surgeons during or after the coronary angiography

  7. length of stay

    Time frame: through study completion, an average of 1 year

    to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital

  8. total cost

    Time frame: through study completion, an average of 3 year

    to assess the total cost in hospital for the initial hospitalization and rehospitalization

  9. individual clinical adverse events

    Time frame: At 1 year after the coronary angiography

    including all-cause death, cardiac death, myocardial infarction, stroke, revascularization of target vessels or transplanted vessels, revascularization for any reason, be admitted to hospital with angina again, readmission for cardiac reasons and readmission for any reason

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease

Acronym: EHEART

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2022
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.